1. Reasons for Amendment

The “Food and Drug Safety Technology Promotion Act” was renamed the “Act on Innovation of Regulatory Science to Support Food and Drug Safety and Commercialization” and wholly amended (Act No. 19694; promulgated on August 16, 2023) to newly insert matters concerning support for commercialization of innovative products and the development of a specialized workforce for regulatory science, and thereby lay and develop the groundwork for regulatory science. Accordingly, this Amendment wholly amends the previous “Enforcement Decree of the Food and Drug Safety Technology Promotion Act” to the “Enforcement Decree of the Act on Innovation of Regulatory Science to Support Food and Drug Safety and Commercialization,” and prescribes matters delegated by the amended Act and matters necessary for the enforcement thereof.

2. Major Provisions

A. Modify the title, names, terms, scope, etc. to match the provisions on regulatory science and innovation of regulatory science set forth in the amended Act (Articles 1 through 4, Article 10, Articles 15 through 18, Article 20).

B. Modify matters concerning Committee operation such as Committee composition, member terms/dismissal, meetings, and sub-committees (Articles 4 through 14).

C. Delete detailed regulations on provisions that have been merged or deleted in the amended Act (current Article 8 and Article 9).

D. Modify conditions for specialized institutions by applying mutatis mutandis the National Research and Development Innovation Act and update actions taken after specialized institution designation (Article 17).

E. Newly insert provisions concerning specialized workforce development agency conditions/requirements, application/designation procedures, etc. (Article 19).

F. Modify matters concerning the scope of delegation/entrustment of authority and conditions for entrusted institutions, etc. (Article 20).